Skip To The Main Content
2022 QR-1988x680

2022 PDA Quality & Regulations Conference

Oct 05 - Oct 06, 2022
Amsterdam, The Netherlands

How Industry and Regulators Will Use Data to Drive Continuous Improvement of Products and Better Patient Outcomes!

  • Conference
  • Europe

left to register

Program Highlights

The agenda is out now – see why you can’t miss this conference!

Download Brochure

New Speaker Alert: We are happy to announce that Alex Viehmann from US FDA is joining us virtually!

Featured Speaker: 
Brian Dooley, EMA; Thomas Larsson, EMA; Thomas Friedli & Matteo Bernasconi, St. Gallen University; Alexander Kammerlocher, Regierungspräsidium Tübingen; Jesper Kjaer, DKMA and Sean Barry, HPRA

Overview

Dear Colleagues, 

“How industry and regulators will use data to drive continuous improvement of products and better patient outcomes.” The recent pandemic has demonstrated the adaptability of humans during a global crisis. The use of novel technologies to manufacture vaccines, the regulatory approaches to see data review as an iterative process during the review of an application, as well as remote quality oversight of manufacturing sites have demonstrated the adaptability of the pharmaceutical / medical device industry.  As we move to the post-pandemic phase, we should not lose these approaches instead they should be fostered as the routine within our organizations. How we use data over the lifecycle of products will become a competitive advantage to any organization that fully embraces “Big Data”.

While there have been many conferences on “Big Data”, the distinguisher for this event is the use of big data from a regulator and industry perspective in the context of quality and regulatory compliance. How do we use data contained within our quality systems, manufacturing sites, labs, etc. to drive continued product and process knowledge? We will listen from regulators, including from the EMA, HPRA, and DKMA, as to how they use data provided by clinical trial sponsors, marketing authorization holders, manufacturers, parallel importers/distributors, post-market complaint and pharmacovigilance data to develop quality oversight. Leading industry speakers will discuss initiatives implemented in case of study format the “how-to” use this data to drive product and process improvements.

Looking forward to seeing you in Amsterdam!

Sincerely, 
The Chairs

Vinny Browning III, Amgen 
Patrick Costello, AbbVie

Scientific Program Planning Committee

  • Vinny Browning III, Amgen (Chair)
  • Patrick Costello, AbbVie (Chair)
  • Karin Baer, NeuroDerm 
  • Daniel Davis, GSK
  • Travis Frick, Adverum
  • Jette Johansen, Novo Nordisk
  • Peter Reichert, Zelect Quality 
  • Eva Urban, CSL Behring
  • Anette Yan Marcussen, Novo Nordisk
  • Glenn Wright, PDA
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe

Agenda

  • Day 1
  • Day 2
  • Wednesday, 05 October 2022

    09:00 I Welcome by the Chairs
    Patrick Costello, AbbVie
    Vinny Browning III, Amgen

    Opening Plenary: Submission
    Moderator: Vinny Browning III, Amgen
    Submissions are a major part of our Industry and also a major part of what our Regulators review to ensure our products are fit for purpose. In this session, we will hear from our Regulators and Industry on how each is applying data to submissions to streamline this process. We will also hear how this helped to get the COVID-19 vaccines/medicines reviewed in an iterative way.

    09:10 I COVID Vaccines/Medicines the Use of Data to Facilitate Rolling (Iterative) Review of Applications
    Thomas Larsson, EMA

    09:35 I Use of Data in Post Approval Change Management Protocol
    Brian Dolley, EMA

    10:00 I A Digitalized way into Submissions
     Angela Currie, AstraZeneca

     

    10:20 I Q&A, Discussion

    10:50
    Coffee Break, Poster Session & Exhibition

    Session 1: Quality Management Systems
    Moderator: Daniel Davis, GSK
    Digitalizing quality systems and using this digital information to produce metrics on Quality Management Maturity (QMM) is an FDA-driven imperative. In this session, we will discuss the Quality System digital transformation journey, both from the vendor and user perspective, and the current thinking on QMM from the PDA QMM Taskforce. Finally, we will examine some of the research that underpins these QMM initiatives and what the future might look like with full adoption of QMM.

    11:20 I Quality Management Maturity
    Mai Viholm, CSL Behring
    Eva Urban on behalf of QMM Task Force by PDA

    11:40 I Digital Quality Transformation: How to Efficiently Enhance Product Quality and Patient Outcomes
    Zillery Fortner, Sparta Systems

    12:00 I Shaping the Future of Manufacturing Quality – From Quality Metrics to Quality Management Maturity and beyond
    Thomas Friedli & Matteo Bernasconi, St. Gallen University

    12:25 I Q&A, Discussion

    12:55
    Lunch Break, Poster Session & Exhibition

    Session 2: Quality Risk Management
    Moderator: Eva Urban, CSL Behring
    Quality Risk Management (QRM) has been introduced many years ago but is still a mystery and challenge for many. ICH has recently published draft guidance for revision 1 of its quality guideline Q9 on QRM. What have been the main drivers for the revision? The session will highlight what stays the same, what has changed, and which aspects have been added or gained more attention in this update, thereby helping to answer the question of whether the new revision is rather a revolution or an evolution. Another key objective will be to present the opportunities and challenges when using data as evidence to support complex decision-making within QRM and the wider Pharmaceutical Quality Systems. One of the focus areas of the revision is clarity on risk-based decision-making (RBDM). The outcome of research for a Ph.D. thesis is shared in terms of the challenges of acquiring, analyzing, interpreting, and verifying data to support RBDM and wider pharmaceutical decision-making within the manufacturing environment. The third part is the identification of the need for a transformation - maturing QRM in pharma companies and connecting the dots and designing a blueprint of a future state QRM approach and The path towards digitalization - how far have we come?

    13:55 - 14:05 I Interactive Questionnaire

    14:05 I Data-Driven Risk-Based Decision Making
    Valerie Mulholland, GMP Services

    14:25 I Transformation and Digitalization of the Quality Risk Management Approach to Make Knowledge Flow
    Michael Schousboe, Novo Nordisk

    14:45 I ICH Q9 R1: The ®Evolution of Quality Risk Management
    Stefan Münch, Körber 

    15:05 I Q&A, Discussion

    15:35
    Coffee Break, Poster Session & Exhibition

    Session 3: Product & Process Surveillance
    Moderator:Jette Johansen, Novo Nordisk
    The session will give some examples of how data can be used to monitor product and process performance in different ways. How a "Holistic Product Review" by use of a digital platform can be used to accelerate the decisions to ensure safe and effective medicines. How an industry-leading program has been able to tie the dots together from product complaints and adverse events, and instantaneously stitch this data with commercial, manufacturing site, quality, regulatory, and public domain data for real-time data analysis. And finally learn how a risk-based approach and statistical tools can be used for monitoring the analytical testing methods used for Quality Control providing increased proactiveness in detecting and anticipating potential testing issues, and opportunities to optimize and strengthen analytical control strategies. All in all, get inspired on how you can increase the monitoring of your process and product performance.

    16:05 I A Holistic Approach to Product Performance Management
    Michael Donald Grischeau, Abbvie

    16:25 I Smart Surveillance (S2) Analytical System
    Peter Eskander, Amgen

    16:45 I Continued Method Verification: Data-Driven Advanced Monitoring of Method Performance and Beyond
    Samantha Hawgood, GSK

    17:05 I Q&A, Discussion

    17:35 I Chairs Conference Summary
    Patrick Costello, AbbVie
    Vinny Browning III, Amgen

    17:45 End of Conference Day 1 & Networking Event

  • Thursday, 06 October 2022

    08:00 – 08:50

    Quality System Interest Group: An Interactive Morning Coffee
    Eva Urban, CSL Behring
    Ghada Haddad, Merck
    The interactive Interest Group Quality Systems session will provide the opportunity to share best practices and challenges during the establishment and implementation of a QMM model.

    09:00

    Opening by the Chairs
    Patrick Costello, AbbVie
    Vinnie Browning III, Amgen

    Session 4: Inspections
    Moderator: Daniel Davis, GSK
    The GMP & GDP inspection landscape has changed unrecognizably following the start of the COVID-19 pandemic and is undergoing further significant shifts. Key drivers for this have been both travel restrictions imposed on inspectors by the pandemic, and the issuance of highly impactful new regulatory requirements such as those contained in EU GMP Annex 1. During this session, we will hear from current and recent ex-regulators on where they see the current and emerging focuses of inspectorates, and how inspectors are undergoing training to meet these new challenges. The adoption of technology and new ways of working to facilitate remote inspections during the pandemic will also be discussed, together with insights on where these new types of inspections are likely to persist in the future.

    09:05 I Current Overview of GMDP Inspection Findings
    Alexander Kammerlocher, Regierungspräsidium Tübingen

    09:30 I Teachings from the Training of Inspectors and Inspector Academy Insights
    Tracy Moore, TM Pharma Group

    09:50 I Remote Regulatory Inspections: Points to Consider and the Use of Technology
    Alex Drapier, GSK

    10:10 I Q&A, Discussion

    10:40
    Coffee Break, Poster Session & Exhibition

    Session 5: Use of Data in GMP / GDP
    Moderator: Eva Urban, CSL Behring
    This session starts with an overview of the current inspections landscape, will inform on hot topics and trends from the industry side, and demonstrate the pros and cons, based on practical experience, of a variety of tools used in inspections incl. virtual and hybrid. It will be demonstrated how reliance can be used to make risk-based regulatory decisions on scheduling inspections and sharing knowledge. Followed by the presentation showing options on how to reduce CO2 emissions in pharma logistics. One possibility to do that is to launch a research project that collects the data of the pharmaceutical cold chain and identifies the relevant environmental criteria such as volume, weight, and temperature excursion rates, which can then be implemented into existing frameworks. It follows a Case study of the Pfizer BioNTech COVID-19 vaccine to explain how a QRM framework was used to design appropriate studies and testing strategies for Container Closure Integrety of the vaccine, explains how QbD principles were applied for the generation of experimental data in a life cycle approach and how a central knowledge management framework was used to define and justify testing and control strategies in manufacturing and presents how the above approaches can be used as a general industry best practice approach.

    11:10 I Sustainability: Opportunities and Challenges to Manage Regulatory GMP/GDP Inspections
    Stephan Rönninger, Amgen

    11:30 I Advancing Sustainable Pharma Supply Chains Through Policy & Research
    Michael Hegglin, Skycell

    11:50 I Applying Quality by Design Principles and a Quality Risk Management Framework to Ensure Container Closure Integrity of a COVID-19 Vaccine Product During Ultra-Cold Chain Storage and Distribution
    Michael Edey, Pfizer
    Derek Duncan, Lighthouse Instruments

    12:10 I Q&A, Discussion

    12:40
    Lunch Break, Poster Session & Exhibition

    Closing Plenary: Regulator Use of Data
    Moderator: Patrick Costello, AbbVie
    The presenters in this session are from two of the leading regulatory authorities in the EU. These presentations will give us insights as to how regulators use data to inform their decision-making around marketing authorizations and to drive better patient outcomes.

    13:40 - 13:50 I Interactive Questionnaire

    13:50 I Use of Real-World Data and Evidence in Europe for Regulatory Decision-Making
    Jesper Kjaer, DKMA

    14:15 I How Regulators Are Using Data to Drive Better Products and Patient Outcomes
    Sean Barry, HPRA

    14:40
    Coffee Break, Poster Session & Exhibition

    15:10 I Coming Soon
    Speaker invited

    15:35 I Q&A & Final Panel Discussion
    Moderator: Patrick Costello, AbbVie

    16:15 I Chairs Conference Summary
    Patrick Costello, AbbVie
    Vinnie Browning III, Amgen

    16:25 I Closing Remarks & Farewell
    Falk Klar, PDA Europe

    16:30
    End of Conference

Highlighted Speakers

Sean Barry
Sean Barry
HPRA
Matteo Bernasconi
Matteo Bernasconi
St. Gallen University
Brian Dooley
Brian Dooley
European Medicines Agency (EMA)
Prof. Dr. Thomas Friedli
Prof. Dr. Thomas Friedli
University of St. Gallen
Alexander  Kammerlocher
Alexander Kammerlocher
Regierungspraesidium Thuebingen
Jesper Kjaer
Jesper Kjaer
DKMA
Thomas Larsson
Thomas Larsson
EMA
Tracy Moore
Tracy Moore
TM Pharma Group Ltd

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hilton Amsterdam

Apollolaan 138
Amsterdam, The Netherlands

Make a Reservation
Hilton Amsterdam
  • Accommodations

    Rate: Single Room € 219 per night*
    Rate: Double Room € 239 per night*

    * Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    Make your reservations as early as possible to guarantee your room. PDA Europe has reserved a limited number of rooms until 15 July 2022.

    Rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

  • Amenities

    Canalside hotel with award-winning restaurant, 15 minutes from airport and right next to the Van Gogh Museum.

    The hotel does not have a shuttle bus

    There are several options for transportation from Schiphol Airport to the hotel. Schiphol is 15KM away from the hotel, and Rotterdam 65KM.

    Limo-service

    The hotel can arrange a private driver to pick you (and fellow travellers) up. The driver will be waiting for you after luggage pick up. The price for this service is 95 euro for a sedan, 110 euro for a mini-van. If you would like to use this service, please inform the hotel at least a few days in advance.

    Car-Sharing (App & membership required)

    Sixt share cares are available at the airport and their entire fleet is hybrid. Follow the signs ‘car rental’ from arrivals and walk your way through the end and take the elevator to -2 .You will find the SIXT parking at row 99. Choose your favorite car , register it on your SIXT app and exit the parking garage.

How to Get Here

By Air

The international airport of Amsterdam is "Schiphol" located 15 km away from the hotel and conference space.

By Car

Parking is available on site, € 45.00 per day. No valid parking.

Other Options

Take the train from Schiphol to Amsterdam Zuid Station (10 minutes). From there you can either walk for approximately 15 minutes or take tram Nr. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. From the tram stop it is about 5 minutes walking to the hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 07 August
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Early Career Professional (Member) €845




Regular Registration
Registration Type Price after 07 August
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €945
Early Career Professional (Member) €945




* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially